Kornimate/medical-research-clean huggingface dataset:
adolescents committed to nutrition and physical activity

Conditions: Overweight; Obesity; Insulin Resistance

Summary: community based participatory research principles will be used to create, implement and evaluate a culturally relevant and age-appropriate obesity intervention for adolescents who are overweight or obese. the intervention will be implemented through school-based health centers (sbhc) and will include clinical encounters with sbhc providers, use of motivational enhancement therapy to help overweight/obese adolescents adopt healthier behaviors, and use of a community advisory council to develop obesity risk reduction strategies that will be delivered by print and digital video disc (dvd) media. to test efficacy of the action intervention, overweight/obese adolescents will be recruited to either the intervention condition or the usual care condition. students will have pre- and post- intervention measurements to assess if adolescents in the intervention condition will have improved risk factor profile for metabolic syndrome, improved nutrition and increased physical activity when compared with students in the usual care condition.


Eligibility criteria:
inclusion criteria: * greater than or equal to the 85th percentile in bmi * in 9th through 11th grades at participating schools exclusion criteria: * bmi greater than or equal to 40 * previously diagnosed type 1 or type 2 diabetes * blood pressure in the range of stage 2 hypertension * medications that significantly interfere with weight

Keywords: adolescent overweight obesity weight loss nutrition physical activity community-based participatory research school-based primary care motivational interviewing
cefepime-taniborbactam vs meropenem in adults with vabp or ventilated habp

Conditions: Ventilator-associated Pneumonia; Hospital-acquired Pneumonia

Summary: this is a phase 3, randomized, multicenter, double-blind, non-inferiority study to evaluate the efficacy and safety of cefepime-taniborbactam compared to meropenem in patients ≥ 18 years of age with ventilated habp or vabp.


Eligibility criteria:
inclusion criteria: * male or female, ≥18 years of age. * the patient or patient's legally authorized/acceptable representative (lar) has voluntarily signed and dated the irb/iec approved icf * meets the clinical diagnosis of ventilated habp or vabp * have at least one of the following clinical criteria: 1. new onset or worsening of pulmonary symptoms and signs 2. new onset or worsening of purulent respiratory secretions 3. hypoxemia 4. need for acute changes in ventilator support * have at least one of the following clinical criteria: 1. documented fever (defined as body temperature ≥ 38°c \[100.4°f\] 2. hypothermia (defined as body temperature ≤ 35°c \[95°f\]) 3. white blood cell (wbc) ≥10,000 cells/mm3 or ≤4,500 cells/mm3 4. \>15% immature neutrophils (bands). * have new or worsening infiltrate on a pulmonary imaging study that is consistent with bacterial pneumonia within 48 hours prior to randomization. * have a lower respiratory tract specimen sent for gram stain and quantitative culture within 36 hours prior to the first dose of study drug. exclusion criteria: * receipt of effective antibacterial treatment for pneumonia for a continuous duration of \>24 hours during the previous 72 hours prior to randomization. * pneumonia known or suspected to be caused by: 1. a bacterial pathogen resistant to meropenem, as assessed by susceptibility testing or against which either one or both study drugs lack activity 2. viruses, atypical bacteria, or fungi * use of non-study systemic gram-negative therapy. * confounding respiratory conditions. * receiving extracorporeal membrane oxygenation (ecmo). * patients with refractory septic shock. * active immunosuppression. * has a history of serious hypersensitivity (e.g., anaphylaxis), serious allergy, or any serious reaction to cephalosporin, penicillin, carbapenem, or other β-lactam antibiotics. * female patients who are pregnant. * patients with egfr \<10 ml/min/1.73 m2 or are receiving or starting renal replacement therapy or expected to require renal replacement therapy during the treatment phase of the study.

Keywords: ventilated pneumonia hospital acquired pneumonia bacterial pneumonia vabp vhabp
singing exercises to improve symptoms of snoring and sleep apnea

Conditions: Snoring; Upper Airway Resistance Syndrome; Obstructive Sleep Apnea

Summary: upper airway resistance during sleep can present with a range of symptoms from simple snoring (ss) through to severe obstructive sleep apnea (osa). pharyngeal narrowing or collapse leads to reduction or cessation in airflow during sleep, and is associated with loud snoring. the investigators hypothesized that regular singing exercises could strengthen pharyngeal muscles and/or increase their resting tone, and lead to an improvement of symptoms and thus quality of life in patients with all forms of snoring.


Eligibility criteria:
inclusion criteria: * age 18 years old or over * history of simple snoring or sleep apnoea with rdi 10-40 exclusion criteria: * severe sleep apnoea rdi \>40 * morbid obesity bmi \> 40 * unable to provide written informed consent

Keywords: snoring sleep apnea pharyngeal muscle tone
effects of corneal anatomical match between donor and recipient during dalk surgery on final visual and refractive outcomes in patients with kcn

Conditions: Keratoconus

Summary: patients with kcn who undergo cornea transplantation divided to 2 groups: group1: after mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea group 2: after mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea after suture removal, best corrected visual acuity, refractive error, corneal keratometry, irregularity of corneal surface and high order aberration of two groups will compare


Eligibility criteria:
inclusion criteria: * patients with kcn who undergo dalk surgery exclusion criteria: * penetrating keratoplasty surgery * other corneal diseases * dystrophies * corneal graft rejection
study efficacy and safety in comparative use of investigational product adjuvant treatment in onychomycosis

Conditions: Onychomycosis

Summary: single-center study, single blind, comparative with the objective of evaluating the efficacy and safety of an investigational product as an adjunct in the treatment of onychomycosis improvement of 90 days ± 2 days.


Eligibility criteria:
inclusion criteria: * volunteers of both sexes; * volunteers aged 18-65 years; * volunteers with onychomycosis confirmed by positive direct mycological nail of hands or feet; * agreement to comply with the test procedures and attend the clinic in the days and times for certain applications and / or assessments; * understand, consent and sign the instrument of consent of clarified. exclusion criteria: * pregnancy or risk pregnancy / lactation; * use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study); * concomitant nail pathologies (psoriasis, lichen planus, etc.); * systemic conditions that may compromise the growth of the nail (vascular disease, diabetes, etc.); * irritation history to similar products to the investigational product; * treatment with antifungal medication prior to the study (up to 12 weeks for systemic medications and topical medications for four weeks); * other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.

Keywords: onychomycosis nail
effects of cpr coaching on leader's performance during simulated cardiac arrest

Conditions: Leadership

Summary: previous studies reported that the introduction of the role of the cpr coach in resuscitation teams led to an increase in the adherence of cpr to aha guidelines by the team. to date, the interaction between the cpr coach and the team leader during the performance of cpr remains poorly studied. in this study, the investigators aim to evaluate whether the interaction between the cpr coach and the team leader brings real benefits to the cognitive engagement of the latter and therefore whether or not his leadership and the overall performance of the team is affected.

in this study, 60 trainees will be divided into 10 teams of 6 participants each, which include two cpr providers, a team leader, a nurse actor, a defibrillator actor with (study groups a and b) or without (control group, c) a coach. each team will perform a standardized 10-minute cardiopulmonary resuscitation (cpr) simulation on a standardized trauma hal mannequin (gaumard scientific) with a combat application tourniquet (cat resources, rock hill, sc)/susie simulator(gaumard scientific, miami, fl) with a cpr feedback device. all participants assigned the role of the coach will receive standardized training as described by cheng et al, 2018. study group a will run the simulation with the cpr coach figure standing next to the defibrillator; study group b will run the simulation with the cpr coach free to move around the scenario; control group c will run the simulation without the cpr coach. during the simulations, an experienced facilitator and a simulation technician will be present to conduct and oversee the progress of the activities. all activities of all teams will be recorded with cameras and microphones. at the end of each simulation, there will be a debriefing conducted by an expert facilitator to make the simulation experience complete but will not be considered in the study. all recorded videos will be viewed by 4 experts who will score the leader's performance and the team's performance. the leader's performance will be evaluated by using the resuscitation team leader evaluation scale (rtle) (grant et al,2012). the team's overall performance will be evaluated by the clinical performance toll (cpt)(donoghue et al, 2010).

Eligibility criteria:
inclusion criteria: * anesthesia trainees * emergency medicine trainees exclusion criteria: * none
family satisfaction (fs) in the intensive care unit

Conditions: Critical Illness

Summary: there is increasing awareness that high-quality care in the intensive care unit also includes care of visiting family members according to their needs. the investigators therefore want to assess family satisfaction using a questionnaire that was specially developed for this setting and recently validated for german-speaking participants.

family members who visit patients on the icu (intensive care unit) are not just onlookers. they experience the process of care along with their loved ones. increasingly, the satisfaction of family members with icu care, decision-making and information, and their empowerment to contribute towards patient care as near relatives, is being perceived as an important aspect of the general quality of icu care. family satisfaction is assessed using the 34-item fs-icu questionnaire which was recently validated for german-speaking participants. the aim of this pilot survey is to identify opportunities for improvement of family satisfaction.

Eligibility criteria:
inclusion criteria: * all visiting family members who consent to participate exclusion criteria: * no more than two family members per patient; * prior participation
human papillomavirus (hpv) vaccination in barretos (pio xii foundation - barretos cancer hospital)

Conditions: Human Papillomavirus; Infection

Summary: project justification: cervical cancer is a serious public health problem in brazil, and is the cause of significant morbidity and mortality among brazilian women. in spite of government efforts to improve the coverage rates of pap tests, the disease-related incidence and mortality rates remain high and the diagnosis is still too late.considering that the chronic human papillomavirus (hpv) related genital infection leads to cervical cancer development, cervical cancer should be the target of primary prevention through vaccination. project objectives: this project aims to evaluate de following vaccination indicators: 1) program acceptance rate; 2) vaccine coverage rate; 3) three-dose completion rate; 4) rescue vaccination demand; 5) adverse event rate; target population: schoolgirls attending the 6th and 7th grades of elementary school (mean age = 11.9 yo). vaccination program: the program adopted the quadrivalent vaccine because it is considered superior to the bivalent vaccine in preventing hpv-induced lesions. in addition to preventing the development of pre-cancer lesions and cervical cancer, the quadrivalent vaccine has also proved to be effective in preventing condyloma, and vaginal and vulvar cancer. the girls received the vaccines doses at their schools (school-based program) and also at the barretos cancer hospital. results: program acceptance rate = 91.8% (95%ci: 87.0%-96.8%); vaccine coverage for 1st, 2nd and 3rd doses = 87.5% (95%ci: 82.9%-92.2%), 86.3% (95%ci: 81.8%-91.1%) and 85.0% (95%ci: 80.5%-89.7%). three dose completion rate = 97.2% (95%ci: 92.0%-100.0%). reasons for dropping out of the vaccination program included: moving out of town (17), lost during follow up (16), guardians' decision but without a reasonable justification (3), girl refused to continue in the program (1) and pregnancy (2). two girls interrupted the vaccination because of adverse events reported by the parents. rescue vaccination demand = 279 girls on the first dose (20.3%; 95%ci: 17.9%-22.8%), 357 on the second dose (26.3%; 95%ci=23.6%-29.1%) and 291 on the third dose (21.7%; 95%ci=19.3%-24.4%). thirty adverse events were recorded or observed in 4,074 doses, providing an adverse event rate of 0.7% (95%ci: 0.5%-1.1%). there was no severe adverse event.


Eligibility criteria:
inclusion criteria:schoolgirls, attending the 6th and 7th grades of the elementary school. exclusion criteria:pregnant and breastfeeding adolescents and girls who did not attend classes.

Keywords: hpv infection cervical cancer hpv vaccine
study of bms-986497 (orm-6151) as a monotherapy, in double and triple combination with azacitidine and venetoclax in participants with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome

Summary: the purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of bms-986497 as a monotherapy, in double combination with azacitidine and in triple combination with azacitidine and venetoclax in participants with relapsed or refractory acute myeloid leukemia (aml) or myelodysplastic syndrome (mds).


Eligibility criteria:
inclusion criteria: * adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (aml) or myelodysplastic syndrome (mds). * detectable levels of cluster of differentiation 33 (cd33) expression. * failed alternative therapies with established benefit. * eastern cooperative oncology group (ecog) performance status ≤2 and adequate organ function. exclusion criteria: * acute promyelocytic leukemia. * clinically active central nervous system leukemia. * active malignant solid tumor. * pregnant or breastfeeding. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: bms-986497 first-in-human orm-6151 acute myeloid leukemia (aml) myelodysplastic syndrome (mds) cluster of differentiation 33 (cd33) g1 to s phase transition 1 (gspt1) open label study
analgesic and antihyperalgesic effects of morphine and buprenorphine

Conditions: Pain

Summary: tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). in the present study we investigate primary and secondary hyperalgesia in healthy volunteers following an experimental first degree burn injury. the objectives are: * to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and buprenorphine). * to investigate if these effects are related to the volunteers individual pain sensitivity

please refer to: ravn p, secher el, skram u, therkildsen t, christrup ll, werner mu (2013) morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. j pain res 6: 23-38. 10.2147/jpr.s36827 \[doi\];jpr-6-023 \[pii\].

Eligibility criteria:
inclusion criteria: * healthy individuals * adequate psychomotor performance to perform pain tests * pain-sensitive or pain-nonsensitive according to prespecified criteria exclusion criteria: * known allergy to morphine or buprenorphine * prior adverse experiences with opioids * history of abuse * females not taking p-pills * skin lesions on the test-sites * suffering from chronic pain * medication with analgesics * bmi \> 28 * smoker

Keywords: opioids analgesia secondary hyperalgesia quantitative sensory testing inflammatory injury
the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia, europe and north and south america. the aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 u/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator) * hba1c (glycosylated haemoglobin a1c) 7.0-10.0% (both inclusive) * body mass index (bmi) 20-45 kg/m\^2 (both inclusive) exclusion criteria: * female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant * recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness * treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening * impaired liver or renal function * uncontrolled treated or untreated hypertension (systolic blood pressure (sbp) equal to or above 180 mmhg and/or diastolic blood pressure (dbp) equal to or above 100 mmhg) * any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial * known or suspected abuse of alcohol or narcotics
evaluation of sagittal abdominal diameter as a predictor of the skin to epidural space distance in obese patients

Conditions: Obesity; Epidural; Anesthesia, Headache

Summary: the aim of this study is to evaluate the use of the sagittal abdominal diameter (sad) as a potential predictor of the skin to epidural space distance (sesd) and to compare its accuracy versus that of the bmi as a previously validated predictor

adult patients from either sex with bmi from 30-39.9 kg/m², scheduled for lower abdominal operations or surgeries on the lower extremities under epidural anesthesia will be eligible. pregnant women will be excluded. the sagittal abdominal diameter (sad), which is the anteroposterior diameter of the abdomen in the supine position at l4-5 level will be measured in all subjects along with the bmi prior to epidural placement. the epidural space will be accessed at the l3-l4 or l4-l5 interspace with a 16-g or 18-g tuohy needle using a loss of resistance to saline technique. the proper placement of the needle in the epidural space will be confirmed by connecting the hub of the epidural needle via a rigid extension tubing to a saline filled pressure transducer to demonstrate the characteristic epidural space pressure wave changes described by arnuntasupakul and his colleagues (2016), which is a pulsatile waveform synchronized with arterial pulsations. the distance from skin to epidural space will be marked on the needle with a sterile marker and will be recorded. an epidural catheter will be passed into the epidural space and the epidural block will be activated in the usual way until adequate sensory and motor block is established in both lower extremities (bromage score 3-4). successful placement of the epidural needle will be considered if the following two criteria are fulfilled: (1) detection of the characteristic epidural pressure wave form as described above and (2) establishment of adequate sensory and motor block. simple linear regression will be used to deduce an equation relating the skin to epidural space distance to the sagittal abdominal diameter or to the bmi.

Eligibility criteria:
inclusion criteria: * age 18 years or older * bmi 30 to 39.9 * either sex * elective surgery on lower extremities performed under epidural anesthesia exclusion criteria: * pregnant women * contraindications to epidural block
mcs in the treatment of lower urinary tract symptoms

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Summary: the hypothesis of the study is to examine whether mcs-2 is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

this is an adaptive trial design, that combines elements of a phase 2b (dose ranging) study and a phase 3 (hypothesis testing) study, the objectives for the two phases are separate. phase 2b objectives: the primary objective of the phase 2b portion of this study is to evaluate, in a treatment-naïve population, the 0 mg (placebo), 15 mg, and 30 mg mcs-2 in terms of dose response and to determine the optimal dose to be used in the phase 3 portion of this trial. the secondary objective of this portion of the study is to evaluate the safety and tolerability of the 15 mg and 30 mg mcs-2. phase 3 objectives: the primary objective of the phase 3 portion of this study is to evaluate, in a treatment-naïve population, the effectiveness of the mcs-2 (at the dosage determined in the phase 2b portion of this study), as compared to mcs placebo (0 mg), in reducing the lower urinary tract symptoms (luts) suggestive of benign prostatic hyperplasia (bph). the secondary objective of this study is to evaluate the safety and tolerability of mcs-2 (at the dosage determined in the phase 2b portion of this study), as compared to mcs placebo (0 mg).

Eligibility criteria:
inclusion criteria: * age ≧ 40 years old * not being treated for bph or luts * psa ≦ 4 ng/ml and no pathologically-proven prostate cancer * i-pss ≥ 10 * no known malignancy * ast/alt ≦ 3x unl * creatinine ≦ 3x unl * subjects who sign the informed consent form exclusion criteria: * subjects' luts are not bph-related * have been treated with pelvis irradiation or pelvic surgery * plan to undergo any invasive procedures within the study period * active infection or inflammation * considered ineligible by the investigators

Keywords: benign prostatic hyperplasia multi-carotenoids mcs-2 lower urinary tract symptoms international prostate symptom scores